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510(k) Data Aggregation

    K Number
    K101088
    Device Name
    EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT
    Manufacturer
    MEDICA CORP.
    Date Cleared
    2011-04-04

    (350 days)

    Product Code
    CIX,CEO,CJY,JGJ
    Regulation Number
    862.1035
    Type
    Traditional
    Panel
    Clinical Chemistry
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EasyRA albumin reagent is intended for the quantitative determination of Albumin (ALB) in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys. For in vitro diagnostic use only.

    The EasyRA total calcium reagent is intended for the quantitative measurement of Total Calcium (Ca) in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety if bone diseases, chronic renal disease and tetany. For in vitro diagnostic use only.

    The EasyRA magnesium reagent is intended for the quantitative measurement of Magnesium (Mg) in human serum and plasma, using the MEDICA "EasyRA Chemistry Analyzer" in clinical laboratories. Magnesium measurements are used in the diagnosis and treatment of: Hypermagnesemia occuring during renal failure, acute diabetic acidosis, dehydration or in Addison's disease. Hypomagnesemia observed in cases of chronic alcoholism, malabsorption, acute pancreatitis and kidney disorders.

    This reagent is intended for the quantitative measurement of Inorganic Phosphorous (PHOS) in human serum and plasma. Phosphorus measurements are used in the diagnosis and treatment of parathyroid gland, kidney diseases, and vitamin D imbalance.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for in vitro diagnostic reagents, not a study describing the performance of an AI-powered medical device. As such, most of the requested information (acceptance criteria, study design, sample sizes, expert involvement, ground truth establishment, MRMC studies, standalone performance) is not applicable or cannot be extracted from this document.

    The document discusses the regulatory clearance of "EasyRA Albumin Reagent, EasyRA Calcium Reagent, Easy RA Magnesium Reagent, Easy RA Inorganic Phosphorus Reagent" for use with the MEDICA "EasyRA Chemistry Analyzer" for quantitative determination of various substances in human serum and plasma.

    Therefore, I cannot provide a table of acceptance criteria, device performance, study details, or information related to AI performance from this document.

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